DiaSorin recalls Simplexa COVID-19 Direct test kits with specific lot numbers due to potential leakage and cross-contamination risks, leading to invalid results and error codes.
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
DiaSorin is recalling certain Simplexa COVID-19 Direct test kits that may leak, causing cross-contamination and invalid results. This could lead to inaccurate test outcomes if the kits are used.
The Direct amplification discs in these kits may leak during use, which can cause cross-contamination with other samples or surfaces. This leakage might lead to invalid test results and error codes on the device.
Home users who purchased the recalled Simplexa COVID-19 Direct test kits with specific lot numbers are most at risk of getting invalid results or cross-contamination.
Check the product's lot numbers: MOL4150/US13950, MOL4150/US14913, MOL4150/US13952, and other specific combinations listed in the recall notice. The kits include Reaction Mix with the same lot numbers.
Look for the lot numbers on the test kit packaging, which include specific combinations like MOL4150/US13950 or MOL4150/US14913.
The Direct amplification discs in these kits may leak, causing cross-contamination and invalid test results.
Check the lot numbers on the packaging to see if your kit is affected. If it is, stop using it and contact DiaSorin for further instructions.
The recalled kits have specific lot numbers listed in the recall notice, such as MOL4150/US13950 or MOL4150/US14913.
We’ve drafted a message you can send DiaSorin to request your refund or repair — edit it as you like.
Subject: Recall Z-1209-2023 — DiaSorin DiaSorin Hello, I own a DiaSorin that is covered by recall Z-1209-2023 from DiaSorin. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
